FDA product code DGR: Whole Human Serum, Antigen, Antiserum, Control
DGR is the FDA product code for whole human serum, antigen, antiserum, control. It is a Class I device, regulated under 21 CFR 866.5700 and reviewed by the Hematology panel. FDA has cleared 5 510(k) submissions under DGR, from 5 different applicants. The average 510(k) review took 72 days (median 51).
Classification
| Field | Value |
|---|---|
| Device name | Whole Human Serum, Antigen, Antiserum, Control |
| Device class | Class I |
| Regulation | 21 CFR 866.5700 |
| Review panel | HE — Hematology |
| Medical specialty | Immunology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every DGR clearance
Top DGR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Consolidated Technologies, Inc. | 1 | 1996-09-24 |
| Boehringer Mannheim Corp. | 1 | 1990-09-05 |
| Bio-Rad | 1 | 1987-01-09 |
| Kallestad Laboratories, Inc. | 1 | 1979-04-04 |
| Beckman Instruments, Inc. | 1 | 1978-08-31 |
Most recent DGR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K961544 | Consolidated Technologies, Inc. | QUALITROL IGAME CONTROLS, LEVELS 1 AND 2 | 1996-09-24 | 155 |
| K902220 | Boehringer Mannheim Corp. | PRECIPATH(R) IM NORMAL & ABNORMAL IMMUNO. CONTROL | 1990-09-05 | 111 |
| K865014 | Bio-Rad | LIQUICHEK IMMUNOLOGY CONTROL (HUMAN) LEVELS I & II | 1987-01-09 | 17 |
| K790298 | Kallestad Laboratories, Inc. | RADIOASSAY, CONTROL SERUM I, II, III | 1979-04-04 | 51 |
| K781355 | Beckman Instruments, Inc. | ICS NORMAL CONTROL SERUM | 1978-08-31 | 24 |
Recalls for DGR devices
openFDA lists no recalls for product code DGR.
Frequently asked questions
What is FDA product code DGR?
DGR is the FDA product code for whole human serum, antigen, antiserum, control. It is a Class I device, regulated under 21 CFR 866.5700 and reviewed by the Hematology panel.
What device class is DGR?
Class I, regulation 21 CFR 866.5700. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code DGR?
Across 5 cleared submissions the average was 72 days from receipt to decision (median 51).
Which companies have the most DGR clearances?
Consolidated Technologies, Inc. (1); Boehringer Mannheim Corp. (1); Bio-Rad (1); Kallestad Laboratories, Inc. (1); Beckman Instruments, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DGR
- Run a recall and safety report across every DGR manufacturer
- Watch product code DGR for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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